Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-25 are pending. Claims 1-25 are examined on the merits.
Claim Objections
Claims 2, and 4-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections –35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 13-14, 16, 19, 21, 24, and 25 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Berndt et al (WO 03084554 A1).
Berndt et al teach NOVELTY A new willow extract (A) contains at least 25 (preferably 30-50, especially 35-45) wt. % salicin (I) (based on the solids content and determined by alkaline saponification). USE - (A) is used in pharmaceutical or cosmetic compositions, specifically pharmaceutical compositions for treating rheumatic diseases or for treating or preventing allergy-induced diseases (all claimed) (thus claims 1 and 3 are met). More generally (A) has antiinflammatory, antipyretic, antiallergic and analgesic activity based on inhibition of cyclooxygenase (especially cyclooxygenase-2), and is useful for treating diseases associated with abnormal arachidonic acid metabolism, especially rheumatic diseases, allergy-induced diseases and dermatological diseases such as psoriasis, urticaria or chronic exanthema of allergic or non-allergic origin. ADVANTAGE - (A) has a higher (I) content than ethanolic willow extracts; has superior pharmacological activity (specifically antiinflammatory activity) to prior art willow extracts; and is easy to incorporate into pharmaceutical dosage forms (especially oral dosage forms). In particular (A) is obtained as stable, loose, free-flowing powder or granules suitable for direct processing (e.g. tableting) (thus oral administering to a patient, a human, thus claims 1 and 24 are met, thus with a carrier, thus claim 14 is met). Berndt et al teach (A) is administered orally or topically (both claimed). Daily dose is 0.5-100 mg/kg (thus an effective amount, thus claim 13 is met, thus at least 0.5 g, thus claim 21 is met). 930 g of willow bark (thus claim 16 is met) (chopped to a particle size of less than 4 mm) was extracted for 5 hours with a mixture of supercritical carbon dioxide and ethanol at 100 bars and 70 °C, at a throughput of 7 kg/hour for supercritical carbon dioxide and 1 l/hour for ethanol (99.9%) (see Equivalent abstract). Berndt et al teach these include, for example, Salix alba, Salix fragilis, Salix triandra, Salix pentandra, Salix nigra, Salix purpurea, Salix cinerea, Salix capria, Salix daphnoides, Salix nigricans and Salix babilonica. Plant parts of Salix daphnoides, Salix babylonica (especially from China) and Salix alba are preferred (page 3, 5th paragraph from the bottom) (thus claim 25 is met). Berndt et al teach the extract is generally administered in a dose of about 0.5 mg to 100 mg/kg body weight per day. It can be given in a single dose (thus claim 19 is met) or in multiple doses (page 5, 8th paragraph). Berndt et al teach Use of a willow extract according to one of claims 1 to 6 for the preparation of a pharmaceutical agent for the treatment of rheumatic diseases or for the preventive or therapeutic treatment of allergic-induced diseases (see claim 13).
Therefore, the reference is deemed to anticipate the instant claim above.
Claim Rejections –35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 3, 13-14, and 16-25 are rejected under 35 U.S.C. 103(a) as being unpatentable over Berndt et al as applied to claims 1, 3, 13-14, 16, 19, 21, 24, and 25 above.
The teachings of Berndt et al are set forth above and applied as before.
The teachings of Berndt et al do not specifically teach the treatment duration in claims 17 and 18; the treatment regimen in claim 20, and the claimed amount of extract in claims 22 and 23.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to vary the treatment duration, regimen and dosage according to the severity of the allergic reaction of the patient. For example, when the allergic reaction is severe, the dosage may increase, the treatment duration may increase, and the administration frequency may increase as well. Although the prior art did not specifically disclose claimed parameters, it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal parameters because willow extracts are art-recognized result effective variables because they have the ability to treat allergic reaction, which would have been routinely determined and optimized in the pharmaceutical art.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 1, 3, and 13-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Zhang et al (Zhang et al, Studies on pharmacology of chemical constituents of leaves of Salix matsudana. Journal of Jilin Agricultural University (2001), Volume 23, Number 1, pp. 54-57), in view of Yu et al (CN 107397817 A).
Zhang et al teach the effects of three compounds isolated from the leaves of Salix matsudana (thus a willow leaf extract, and the only active ingredient, thus claims 1 and 2 are met) on arachidonic acid metabolism and norepinephrine (NE)-induced lipolysis in rat platelets were studied. The results showed that these compounds selectively inhibited the yield of arachidonic acid metabolism, 12-HETE (12-hydroxy-5,8,10,14-eicosatetraenoic acid), indicating that these compounds could prevent and cure allergy (thus therapeutically effective amount, for treating allergic reaction, thus claims 1-3 are met) and arteriosclerosis. The product of apigenin-7-O-β-D-glucopyranoside hydrolysis was apigenin, which could inhibit the yield of TXB2 (thromboxane B2). NE-induced lipolysis of fat cells in normal rats testicle showed that the three compounds can promote lipolysis (see Abstract).
Zhang et al do not teach orally administering to a patient.
Yu et al teach the invention of a willow leaf extract preparation comprises the willow leaf extract. Preferably, the willow leaf extract preparation further comprises pharmaceutically acceptable auxiliary material. The invention of willow leaf extract in the preparation may further contain or does not contain other pharmaceutically acceptable component with function of decreasing pressure. The invention of willow leaf extract preparation can be any suitable oral preparation, including but not limited to tablet, pill (comprising a dropping pill), hard capsule, soft capsule, granule, powder, oral liquid, drop and so on (see Abstract).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to take willow leaf extract from Zhang et al orally since Yu et al teach the invention of willow leaf extract preparation can be any suitable oral preparation, including but not limited to tablet, pill (comprising a dropping pill), hard capsule, soft capsule, granule, powder, oral liquid, drop and so on. Since both of the references teach willow leaf ethanol extract, one of ordinary skill in the art would have been motivated to combine the teachings of the references together.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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